Senior Officer

Responsibilities

• Review of RM, PM, SFG, FG, Stability, In-process stage, Cleaning validation, In-process validation, documents related to events like OOS, Incident, OOT, Reanalysis, hypothesis analysis, water analysis, environment monitoring reports, trends, calibrations, instrument verification, working standards.
• Approval of SFG, FG, Stability, In-process stage, Cleaning validation, In-process validation, documents related to events like OOS, Incident, OOT, Reanalysis, hypothesis analysis, environment monitoring reports, trends, calibrations, instrument verification, working standards.
• Review and approval for the On-line activities like Sample set methods, sequences, standalone instruments data, time events, volumetric solution preparation records.
• Requests approval in SAP for Reprint requests, error logs, extra copy prints through SAP as per requests of reprints of TDS.
• Review in SAP for RM, PM, SFG, FG(Review only), Stability, water, calibrations data.
• Approval in SAP for SFG, FG(Review only), Stability, calibrations data.
• Sign off2 for Standalone instruments and HPLC/GC.
• Reconciliation of Standalone instruments, HPLC, GC for analytical data.
• Filing and SAP e-register entries of Stability Data, and submission of data in Documentation cell.
• Quarterly review of QC lab Log books.
• Review / closure of e log book entries related to analysis, instruments usage, working standard consumption, chemical usage entries.
• Manual COA preparation, checking and approval for SFG and FG as per requirements.
• Reconciliation of B type SOP formats through SAP.
• To complete the training assigned in ASPIRE and to attend the routine training assigned.
• To verify and check the number of samples for analysis (chemical and micro) received in stability section.
• To prepare, review and check the trends of FG/SFG by mini-tab.
• To review, check and approve the CSV and AMV protocols and reports.
• To follow any other instruction given by reporting authority or department head.
• To review and approve the electronic data of stability chamber in ICDAS application software.
• Approval of TDS, Protocols and reports, SOP formats In Open text.
• Completion of tasks In Track-wise related to LER, CFT, OOS, OOT, CAPA, CC, incidents.
• Execution and completion of Code to code tasks assigned to AQA in SAP for RM, PM, SFG
• Investigation and documentation for events related of Data Mining observation for AQA team members.
• To perform monthly review of standalone and chromatographic system in data mining activity.
• 100% verification of released plates of MLT, AET , EM , Water , Rinse/ Swab on colony counter as well as pathogen plates.
• Water and EM trend review and approval.
• Handing and reconciliation of Placebo.
• Storage, reconciliation and destruction of Nasal SFG stage sample..

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